Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442644
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-03
Brief Title:
Live Music in the Intensive Care Unit
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
Live Music in the Intensive Care Unit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this quasi-experimental pre- post test study is to test a patient-tailored live music interventions effect on stress and pain reduction in adult critically ill patients admitted to the intensive care unit
The main question it aims to answer is
Does live music reduce stress and pain in adult intensive care patients
In the pre-post test design the patients will be their own control There will be no randomisation Researchers will compare measurements of heartrate respiration rate heartrate variability blood pressure and pain before and after the live music intervention to see if live music effects these vital parameters
Participants will listen to live music in their room in the intensive care unit for 5 to 15 minutes
The main question it aims to answer is
Does live music reduce stress and pain in adult intensive care patients
In the pre-post test design the patients will be their own control There will be no randomisation Researchers will compare measurements of heartrate respiration rate heartrate variability blood pressure and pain before and after the live music intervention to see if live music effects these vital parameters
Participants will listen to live music in their room in the intensive care unit for 5 to 15 minutes
Detailed Description:
1 Introduction The intensive care unit ICU has been and is still undergoing paradigmatic changes and technological advancements meaning that an increased number of patients are conscious during their ICU stay and more survive to remember their ICU admission Patients are admitted to the ICU because they are in urgent need of life saving treatments However an ICU admission can be a traumatic experience for patients and their relatives The ICU patient room is designed with the purpose of promoting advanced care and treatment performed by the healthcare professionals However the room leaves little space for positive sensory inputs for the patients and the relatives rather the environment is a highly technological noisy unfamiliar and often frightening experience for the patients and their relatives - memories of this may follow them for years In this project the investigators aim to test patient-tailored live music as an intervention to reduce stress and pain for adult ICU patients
2 Project aim The aim of this study is to test a patient-tailored live music interventions effect on stress reduction in adult critically ill patients admitted to the intensive care unit
3 Design and analysis method The study is a quasi-experimental pre- post test study with patients being their own control The pre-post test measurements will be carried out at predefined time points 5 minutes before and 5 minutes after the intervention Our primary outcome the HRV will be measured continuously 5 minutes before the music intervention during the whole intervention and 5 minutes after the intervention There will be no randomisation
Relevant static calculations will be performed using Stata Statistical analysis will be supported by a statistician at CONNECT A data support centre for clinical and genomic data
4 Music intervention This study will be performed in collaboration with the Royal Academy of Music Aarhus Denmark RAMA and ICU departments across Central Denmark Region Aarhus University Hospital being main investigator
The musicians have participated in a training programme after which they are able to carry out one-on-one patient-tailored music sessions for adult patients at the ICU carried out in the patients room
Each music intervention comprises three components 1 A prior briefing by the nurse on the patients condition relevant for the musical practice 2 A patient-tailored live music session in the patient room and 3 A debriefing with the nurse
The musicians plan a programme for each intervention day and the patients will therefore not have the opportunity to choose specific pieces of music The musicians prepare a mix of relaxing soothing familiar and unknown music with low-pitched instruments eg guitar and piano in a slow tempo 60-80 beats per minute with a predictable musical structure rhythm and tonality as it has been shown that low-pitched and low-intensity music may be calming and may regulate arousal levels The length of the music intervention will range from 5 to 15 minutes depending on how many music pieces the patient wants to listen to or based on the nurses assessment of the patients condition
5 Sample size Aarhus University Hospital is the main research centre but the study is a multi-centre study with participation of the Regional Hospitals of Gødstrup Horsens and Viborg all have agreed to participate The intervention is fully implemented at all hospitals
The sample size is calculated based on an estimated population of 1103 corresponding to the patients receiving the intervention at all four sites annually The investigators have determined that a sample size of 202 is needed to estimate the effect with a confidence level of 95 margin of error of 5 and population proportion of 80
Patients will be included consecutively
6 Project organisation and feasibility As Aarhus University Hospital is the main study site and also the largest the investigators will include the majority of patients This means that the investigators will have a larger percentage of the total sample size than the regional hospitals A project nurse will collect data at each site
The project group consists of one project nurse and one nurse manager at each site
Furthermore the group consists of Professor in Nursing at Aarhus University Hospital Pia Dreyer Associate Professor at The Royal Academy of Music AarhusAalborg Margrethe Langer Bro project nurse Linette Thorn and the main applicant The results from this pretest-posttest study will be published in a peer-reviewed journal eg Nursing in Critical Care Results will also be presented at national and international conferences
7 Impact of the project Instead of being exposed to an unpleasant room with little opportunity to rest their minds patients together with their relatives will be given the opportunity to experience positive musical stimuli that bring pleasant experiences and memories which may support the patients mental well-being and rehabilitation both in the short and long term The project has the potential to be implemented in more ICU departments across Denmark and potentially also in a broad range of non-ICU hospital departments
2 Project aim The aim of this study is to test a patient-tailored live music interventions effect on stress reduction in adult critically ill patients admitted to the intensive care unit
3 Design and analysis method The study is a quasi-experimental pre- post test study with patients being their own control The pre-post test measurements will be carried out at predefined time points 5 minutes before and 5 minutes after the intervention Our primary outcome the HRV will be measured continuously 5 minutes before the music intervention during the whole intervention and 5 minutes after the intervention There will be no randomisation
Relevant static calculations will be performed using Stata Statistical analysis will be supported by a statistician at CONNECT A data support centre for clinical and genomic data
4 Music intervention This study will be performed in collaboration with the Royal Academy of Music Aarhus Denmark RAMA and ICU departments across Central Denmark Region Aarhus University Hospital being main investigator
The musicians have participated in a training programme after which they are able to carry out one-on-one patient-tailored music sessions for adult patients at the ICU carried out in the patients room
Each music intervention comprises three components 1 A prior briefing by the nurse on the patients condition relevant for the musical practice 2 A patient-tailored live music session in the patient room and 3 A debriefing with the nurse
The musicians plan a programme for each intervention day and the patients will therefore not have the opportunity to choose specific pieces of music The musicians prepare a mix of relaxing soothing familiar and unknown music with low-pitched instruments eg guitar and piano in a slow tempo 60-80 beats per minute with a predictable musical structure rhythm and tonality as it has been shown that low-pitched and low-intensity music may be calming and may regulate arousal levels The length of the music intervention will range from 5 to 15 minutes depending on how many music pieces the patient wants to listen to or based on the nurses assessment of the patients condition
5 Sample size Aarhus University Hospital is the main research centre but the study is a multi-centre study with participation of the Regional Hospitals of Gødstrup Horsens and Viborg all have agreed to participate The intervention is fully implemented at all hospitals
The sample size is calculated based on an estimated population of 1103 corresponding to the patients receiving the intervention at all four sites annually The investigators have determined that a sample size of 202 is needed to estimate the effect with a confidence level of 95 margin of error of 5 and population proportion of 80
Patients will be included consecutively
6 Project organisation and feasibility As Aarhus University Hospital is the main study site and also the largest the investigators will include the majority of patients This means that the investigators will have a larger percentage of the total sample size than the regional hospitals A project nurse will collect data at each site
The project group consists of one project nurse and one nurse manager at each site
Furthermore the group consists of Professor in Nursing at Aarhus University Hospital Pia Dreyer Associate Professor at The Royal Academy of Music AarhusAalborg Margrethe Langer Bro project nurse Linette Thorn and the main applicant The results from this pretest-posttest study will be published in a peer-reviewed journal eg Nursing in Critical Care Results will also be presented at national and international conferences
7 Impact of the project Instead of being exposed to an unpleasant room with little opportunity to rest their minds patients together with their relatives will be given the opportunity to experience positive musical stimuli that bring pleasant experiences and memories which may support the patients mental well-being and rehabilitation both in the short and long term The project has the potential to be implemented in more ICU departments across Denmark and potentially also in a broad range of non-ICU hospital departments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None